Erbe ESU Model VIO® 3n with Accessories

The Erbe ESU Model VIO 3n is an electrosurgical unit that delivers high-frequency electrical current for cutting and/or coagulation of tissue during surgical procedures. It features a touchscreen interface, multiple monopolar and bipolar modes, and is available in 5 different configurations (Fire, Metal, Stone, Water, Timber) with varying functionality levels.

The subject device has a lower maximum power output (360 watts vs. 400 watts in the predicate), supports up to 3 HF instrument sockets (vs. 4 in the primary predicate), includes an additional service interface beyond the predicate, operates at 350 kHz with monopolar and bipolar HF electrical current, and runs software version V1.1.0. It is available in 5 configurations compared to the predicate's single configuration.

IEC 60601-1 and IEC 60601-2-2 (electrical safety); IEC 60601-1-2 (electromagnetic compatibility); IEC 62304 (software verification); FDA Guidance on Electrosurgical Devices for General Surgery, EMC of Medical Devices, Device Software Functions, and Cybersecurity in Medical Devices.

The subject device shares the same intended use, fundamental technology (HF electrical current delivery), and operating principle as the predicate devices. Although differences exist in software version, power output, number of configurations, and external interfaces, side-by-side tissue testing validated that cutting and coagulation performance remains equivalent to the predicate. Compliance with applicable electrical safety, EMC, and software standards demonstrates these technological differences do not raise new safety or effectiveness concerns.